The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants
NCT ID: NCT07322731
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-15
2026-06-15
Brief Summary
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Detailed Description
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The intervention consists of a 15-minute massage administered three times daily for three consecutive days by a trained researcher. Massage includes gentle stroking and circular movements of the legs, arms, back, and hands, following a standardized protocol. Physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation), sleep patterns (using actigraphy and chronometer), and behavioral assessments using the Premature Infant Comfort Scale and Neonatal Stress Scale will be recorded before and after the intervention.
Data will be analyzed using SPSS version 25. Group homogeneity will be assessed with chi-square or Fisher's exact tests, within-group comparisons with paired t-tests, and between-group comparisons with independent t-tests. Significance will be set at p \< 0.05. This study aims to provide evidence on the efficacy of massage therapy as a non-pharmacological intervention to improve preterm infants' comfort, reduce stress, and enhance sleep quality in NICU settings.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group
Preterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care.
Infant Massage Therapy
Preterm infants receive a standardized massage therapy protocol three times daily for 15 minutes over 3 days. The massage is applied by a trained nurse and includes legs, arms, and back following a structured sequence.
Control - Standard Care
Preterm infants receiving standard care only, without massage intervention.
No interventions assigned to this group
Interventions
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Infant Massage Therapy
Preterm infants receive a standardized massage therapy protocol three times daily for 15 minutes over 3 days. The massage is applied by a trained nurse and includes legs, arms, and back following a structured sequence.
Eligibility Criteria
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Inclusion Criteria
* Admitted to the neonatal intensive care unit (NICU).
* Medically stable and cleared for massage therapy by neonatologist.
* Parental/guardian consent obtained.
Exclusion Criteria
* Infants requiring mechanical ventilation or intensive respiratory support.
* Infants with known neurological disorders.
* Parental/guardian refusal or inability to participate.
35 Months
37 Months
ALL
No
Sponsors
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Yuzuncu Yil University
OTHER
Responsible Party
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Rıdvan Akdogan
Assistant Professor
Locations
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Van Regional Training and Research Hospital
Van, Turkey, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YUZUNCU_YIL_UNIVERSITY_NICU
Identifier Type: -
Identifier Source: org_study_id
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